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The Effects of Sufentanil vs. Remifentanil in Total Intravenous Anesthesia With Remimazolam on Postoperative Pain

The Effects of Sufentanil-remimazolam vs. Remifentanil-remimazolam Total Intravenous Anesthesia on Postoperative Pain in Laparoscopic-assisted Gastrectomy - A Randomized, Controlled Study-

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05785234
Enrollment
66
Registered
2023-03-27
Start date
2023-04-30
Completion date
2025-06-30
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Brief summary

In this study, the investigators evaluate the effect of total intravenous anesthesia using sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain in patients undergoing laparoscopic gastrectomy.

Interventions

DRUGsufentanil-remimazolam group

Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 0.5 ng·ml-1 of sufentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 0.2 - 0.6 ng·ml-1 of sufentanil.

DRUGremifentanil-remimazolam group

Induction of general anesthesia with 6mg·kg-1·h-1 of remimazolam combined with 4 ng·ml-1 of remifentanil. Maintenance of general anesthesia with 1-2mg·kg-1·h-1 of remimazolam combined with 2-6 ng·ml-1 of remifentanil.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 20years or older 2. Scheduled for laparoscopic-assisted gastrectomy 3. American Society of Anesthesiologists(ASA) physical status I and III

Exclusion criteria

1. Emergency operation 2. Patients with a history of severe hypersensitivity reaction to dextran 40 3. Patients who cannot use patient controlled analgesia(PCA) 4. Patients with morbid obesity \[body mass index (BMI) \>35 kg/m2\] 5. Patients with history of uncontrolled hypertension (diastolic BP \>110mmHg) or DM 6. Patients with history of heart failure (unstable angina, congestive heart failure) 7. Patients with history of liver failure, renal failure, allergic to medicine 8. Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia) 9. Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression) 10. Patients with obstructive sleep apnea 11. Patients who cannot read the consent form (examples: Illiterate, foreigner) 12. Patients who withdraw the consent

Design outcomes

Primary

MeasureTime frameDescription
Total consumption of fentanyl in 24 hours after surgeryafter 24 hours postoperative periodTo investigate the effect of total intravenous anesthesia with intraoperative sufentanil-remimazolam and remifentanil-remimazolam on postoperative pain, total cumulative dose of fentanyl was measured for the first postoperative 24 hour.

Countries

South Korea

Contacts

Primary ContactSun Joon Bai, MD, PhD
SJBAE@yuhs.ac82-2-2228-4438

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026